Can squeezing while stimulating beat stimulation alone for leakage?

NCT ID NCT07604415

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This study tests whether doing active anal sphincter squeezes during home-based electrical stimulation works better than electrical stimulation alone for people with fecal incontinence. 24 adults with at least monthly leakage will be randomly assigned to one of two groups and use a device at home for 12 weeks. The main goal is to see if the active group has a greater reduction in incontinence severity scores.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
home-based anal electrical stimulator (NeuroTrac Continence device)
What this could lead to
If it works, this could point toward a more effective home treatment for fecal incontinence, improving quality of life without surgery.
What could go wrong
This is a small early-stage trial with only 24 participants, so results may not apply to everyone. The improvement from adding active contractions might be small or not meaningful.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 24 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2026

Expected to finish

May 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Signed informed consent * Age ≥18 years * Diagnosis of fecal incontinence (urge, passive, or mixed type) with at least 1 episode of involuntary stool leakage requiring hygiene intervention or underwear change per month for ≥3 months * Vaizey (St. Mark's) Incontinence Score ≥8 * Ability to understand study procedures and comply with the 12-week home intervention * Willingness to attend all study visits and assessments * Stable medical management for fecal incontinence for at least 4 weeks prior to enrollment Exclusion Criteria: * Complete spinal cord injury above the conus medullaris * Active inflammatory bowel disease flare requiring systemic therapy or not in clinical remission * Rectal prolapse requiring surgical intervention * Severe symptomatic hemorrhoids interfering with anorectal assessments or device use * Active anal fissure or perianal fistula * Active colorectal cancer or history of colorectal cancer within 5 years * Colorectal surgery within the previous 6 months * Pregnancy or planned pregnancy during study participation * Implanted cardiac pacemaker or defibrillator * Other implanted electrical devices contraindicating electrical stimulation * Previous specialized pelvic floor physiotherapy, biofeedback therapy, EMG-guided rehabilitation, or anal electrical stimulation within 3 months prior to randomization * Cognitive impairment preventing understanding of study procedures or informed consent * Uncontrolled severe diarrhea (\>5 liquid stools/day) * Anal stenosis preventing probe insertion * Severe anal sphincter defect (\>120° on ultrasound) requiring surgical repair * Isolated severe rectal sensory dysfunction without significant sphincter dysfunction * Previous pelvic radiotherapy * Concurrent participation in another interventional clinical trial

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Conditions

The condition(s) this trial relates to.

Fecal Incontinence

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

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  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

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  3. A doctor treating you

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Contacts and locations

Locations

  • Clinic of Internal Medicine- Gastroenterology, University Hospital Martin

    RECRUITING

    Martin, 03601, Slovakia

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